Tissue matrices and methods of treatment

ABSTRACT

Methods, systems, and compositions for treatment are provided. The methods can be used to stretch and completely or nearly completely wrap a composition around an implant or tissue expander. The systems can be used to protect an implant or tissue expander by completely or nearly completely wrapping a composition around the implant or tissue expander. The compositions can be used to completely or nearly completely wrap around an implant or tissue expander to provide support and protection to the implant or tissue expander.

This application is a continuation of U.S. patent application Ser. No.15/139,458, filed Apr. 27, 2016, which claims the benefit of priority toU.S. Prov. Patent App. No. 62/161,971, filed on May 15, 2015, each ofwhich is incorporated herein by reference in its entirety.

The present disclosure relates to methods of treatment, and moreparticularly, to methods of treatment and compositions and systems fortreatment in accordance with the methods.

Various methods are used for breast augmentation or reconstruction. Onemethod involves sub-glandular placement of breast implants or tissueexpanders, a procedure that is generally considered less complicatedcompared to other techniques because the pectoral muscles are leftintact, resulting in shorter operation times, lower pain levels, andshorter recovery times. However, placing breast implants or tissueexpanders in a sub-glandular palpability of the implant, superficialripples, and a potential for capsular contracture.

Rippling can occur in patients with inadequate breast tissue forcovering the implant or tissue expander, resulting in folds or wrinklesin the implant or tissue expander that are visible through the skin. Inparticular, since the implant or tissue expander is placed over thepectoral muscles, there may be inadequate breast tissue to cover theimplant or tissue expander. Rippling is typically most noticeable on thebottom or sides of the implant or tissue expander, but may also occur inthe middle near the cleavage.

Capsular contracture can occur as a response of the immune system toforeign materials in the human body. In particular, capsular contractureinvolves the formation of capsules of tightly woven collagen fiberscreated by the immune response to the presence of foreign objects, suchas implants or tissue expanders, in the body. The collagen-fiber capsuletightens and squeezes the breast implant or tissue expander, resultingin pain and discomfort to the patient, as well s a distortion of thebreast implant or tissue expander.

Various products are used as protective sleeves to completely surroundthe breast implant or tissue expander prior to sub-glandularimplantation. For example, some products are formed from completelysolid sheets of acellular dermal matrix (ADM) that are trimmed toconform to the size of and wrap around the breast implant or tissueexpander, and are sutured around the breast implant or tissue expander.Berna, G. et al., “Evaluation of A Novel Breast Reconstruction TechniqueUsing the Braxon® Acellular Dermal Matrix: A New Muscle-Sparing BreastReconstruction”, ANZ J. Surg. (Sep. 29, 2014), doi: 10.1111/ans.12849.Such products, however, cover the entire surface of the implant ortissue expander, and therefore require a substantial amount of tissue,resulting in an expensive product. Further, trimming the excess tissueto conform to the size of the breast implant or tissue expander resultsin a waste of tissue.

To cover an implant or tissue expander, it may be desirable to use acomposition that has one or more mesh patterns that facilitatestretching and expanding the composition to completely or nearlycompletely wrap around the implant or tissue expander, while providingthe necessary coverage and support to the implant or tissue expander.Accordingly, methods of treatment including compositions, as well ascompositions and systems used in the methods, are provided.

According to certain embodiments, a method of treatment is provided. Themethod can include providing a composition. The composition can includea tissue matrix or synthetic material defining a composition body. Thecomposition can include at least one mesh pattern formed in at least aportion of the composition body. The method can include stretching andexpanding the composition body at the mesh pattern to completely ornearly completely wrap the composition around or position thecomposition onto an implant or a tissue expander. The mesh patternallows less material to be used to form the composition body, whileproviding the necessary support and/or coverage to the implant or tissueexpander with the composition.

In certain embodiments, the tissue matrix can be a tissue matrix sheetdefining a planar and flexible configuration. In certain embodiments,the tissue matrix can be an acellular tissue matrix. In certainembodiments, the tissue matrix can be an acellular dermal matrix.

In certain embodiments, the composition can include a central region andfour extensions extending from the central region. The method caninclude forming the mesh pattern in at least one of the four extensions.The method can include forming the mesh pattern in the central region.The method can include interlocking two of the four extensions of thecomposition with a fastening element. The method can include feeding thefastening element through the mesh pattern and interlocking thefastening element to a strip of material associated with the meshpattern. In certain embodiments, the method can include interlocking thefour extensions of the composition with a fastening element, e.g., aT-shaped fastening element.

In certain embodiments, the composition can include a top region, acentral region, and a bottom region. The composition can include a firstflap and a second flap extending from opposing sides of the centralregion. The composition can include at least one strap integrally formedadjacent to an edge of the bottom region. The method can includestretching the at least one strap around a portion of the implant ortissue expander to maintain the composition in a wrapped configuration.

In certain embodiments, the composition can include two flaps extendingfrom one edge of the composition body. The method can include passingthe two flaps through slits of the mesh pattern to maintain thecomposition completely or nearly completely wrapped around the implantor tissue expander.

In certain embodiments, the composition can include a first compositionhalf and a second composition half. The first composition half caninclude two flaps extending from a top edge and two flaps extending froma bottom edge. The method can include passing the two flaps extendingfrom the top edge of the first composition half into slits of the meshpattern of one edge of the second composition half. The method caninclude passing the two flaps extending from the bottom edge of thefirst composition half into slits of the mesh pattern of an opposingedge of the second composition half. Interlocking the flaps with theslits of the mesh pattern maintains the composition completely or nearlycompletely wrapped around the implant or tissue expander.

According to certain embodiments, a composition for treatment isprovided. The composition can include a composition body and a meshpattern formed in at least a portion of the composition body. Thecomposition body can be formed from a tissue matrix or syntheticmaterial. The composition body can be configured to stretch and expandat the mesh pattern to completely or nearly completely wrap thecomposition body around or position the composition body onto an implantor tissue expander.

In certain embodiments, the tissue matrix can be a tissue matrix sheetdefining a planar and flexible configuration. In certain embodiments,the tissue matrix can be an acellular tissue matrix. In certainembodiments, the tissue matrix can be an acellular dermal matrix.

In certain embodiments, the composition body can include a centralregion and four extensions extending from the central region. At leastone of the four extensions can include the mesh pattern formed therein.The central region can include the mesh pattern formed therein. Thecomposition can include a fastening element configured to interlock atleast two of the four extensions relative to each other (e.g., twoopposing extensions). In certain embodiments, the fastening element caninclude a linear elongated body. In certain embodiments, the fasteningelement can define a T-shape.

In certain embodiments, the composition body can include a top region, acentral region, and a bottom region. The composition can include a firstflap and a second flap extending from opposing sides of the centralregion. The composition can include at least one strap integrally formedadjacent to an edge of the bottom region. The at least one strap can beconfigured to stretch around a portion of the implant or tissue expanderto maintain the composition body in a wrapped configuration.

In certain embodiments, the composition body can include two flapsextending from one edge of the composition body. The two flaps can beconfigured to pass through slits of the mesh pattern to maintain thecomposition body completely or nearly completely wrapped around theimplant or tissue expander.

In certain embodiments, the composition body can include a firstcomposition half and a second composition half. The first compositionhalf can include two flaps extending from a top edge and two flapsextending from a bottom edge. In certain embodiments, the firstcomposition half can include two flaps extending from a top edge and thesecond composition half can include two flaps extending from a bottomedge. The two flaps extending from the top edge of the first compositionhalf can be configured to pass into slits of the mesh pattern of oneedge of the second composition half. The two flaps extending from thebottom edge of the first composition half can be configured to pass intoslits of the mesh pattern of an opposing edge of the second compositionhalf. Interlocking of the flaps with the mesh pattern maintains thecomposition completely or nearly completely wrapped around the implantor tissue expander.

According to certain embodiments, a system for treatment is provided.The system can include a composition. The composition can include atissue matrix or synthetic material defining a composition body. Thecomposition can include a mesh pattern formed in at least a portion ofthe composition body. The system includes an implant or a tissueexpander. The composition body can be configured to stretch and expandat the mesh pattern to completely or nearly completely wrap thecomposition body around or position the composition body onto theimplant or tissue expander.

In certain embodiments, the tissue matrix can be a tissue matrix sheetdefining a planar and flexible configuration. In certain embodiments,the tissue matrix can be an acellular tissue matrix. In certainembodiments, the tissue matrix can be an acellular dermal matrix.

In certain embodiments, the composition body can include a centralregion and four extensions extending from the central region. At leastone of the four extensions can include the mesh pattern formed therein.The central region can include the mesh pattern formed therein. Thecomposition can include a fastening element configured to interlock atleast two of the four extensions relative to each other (e.g., twoopposing extensions). In certain embodiments, the fastening element caninclude a linear elongated body. In certain embodiments, the fasteningelement can define a T-shape.

In certain embodiments, the composition body can include a top region, acentral region, and a bottom region. The composition can include a firstflap and a second flap extending from opposing sides of the centralregion. The composition can include at least one strap integrally formedadjacent to an edge of the bottom region. The at least one strap can beconfigured to stretch around a portion of the implant or tissue expanderto maintain the composition body in a wrapped configuration.

In certain embodiments, the composition body can include two flapsextending from one edge of the composition body. The two flaps can beconfigured to pass through slits of the mesh pattern to maintain thecomposition body completely or nearly completely wrapped around theimplant or tissue expander.

In certain embodiments, the composition body can include a firstcomposition half and a second composition half. The first compositionhalf can include two flaps extending from a top edge and two flapsextending from a bottom edge. In certain embodiments, the firstcomposition half can include two flaps extending from a top edge and thesecond composition half can include two flaps extending from a bottomedge. The two flaps extending from the top edge of the first compositionhalf can be configured to pass into slits of the mesh pattern of oneedge of the second composition half. The two flaps extending from thebottom edge of the first composition half can be configured to pass intoslits of the mesh pattern of an opposing edge of the second compositionhalf. Interlocking of the flaps with the mesh pattern maintains thecomposition completely or nearly completely wrapped around the implantor tissue expander.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is front view of a breast implant or tissue expander, accordingto certain embodiments.

FIG. 2 is a side view of a breast implant or tissue expander, accordingto certain embodiments.

FIG. 3 is a front view of a composition, according to certainembodiments.

FIG. 4 is a front view of a fastening element, according to certainembodiments.

FIG. 5 is a perspective view of a fastening element, according tocertain embodiments.

FIG. 6 is a perspective view of a composition in a partially wrappedconfiguration relative to a breast implant or tissue expander, accordingto certain embodiments.

FIG. 7 is a perspective view of a composition in a partially wrappedconfiguration relative to a breast implant or tissue expander, accordingto certain embodiments.

FIG. 8 is a front view of a fastening element, according to certainembodiments.

FIG. 9 is a perspective view of a fastening element, according tocertain embodiments.

FIG. 10 is a perspective view of a composition in a partially wrappedconfiguration relative to a breast implant or tissue expander, accordingto certain embodiments.

FIG. 11 is a front view of a composition, according to certainembodiments.

FIG. 12 is a side view of a composition in a wrapped configurationrelative to a breast implant or tissue expander, according to certainembodiments.

FIG. 13 is a rear view of a composition in a wrapped configurationrelative to a breast implant or tissue expander, according to certainembodiments.

FIG. 14 is a front view of a composition, according to certainembodiments.

FIG. 15 is a perspective view of a composition in a wrappedconfiguration relative to a breast implant or tissue expander, accordingto certain embodiments.

FIG. 16 is a front view of a first composition half, according tocertain embodiments.

FIG. 17 is a front view of a second composition half, according tocertain embodiments.

FIG. 18 is a perspective view of a first composition half and a secondcomposition half in a wrapped configuration relative to a breast implantor tissue expander, according to certain embodiments.

DESCRIPTION OF CERTAIN EXEMPLARY EMBODIMENTS

Reference will now be made in detail to certain exemplary embodimentsaccording to the present disclosure, certain examples of which areillustrated in the accompanying drawings. Wherever possible, the samereference numbers will be used throughout the drawings to refer to thesame or like parts.

In this application, the use of the singular includes the plural unlessspecifically stated otherwise. In this application, the use of “or”means “and/or” unless stated otherwise. Furthermore, the use of the term“including”, as well as other forms, such as “includes” and “included”,is not limiting. Any range described herein will be understood toinclude the endpoints and all values between the endpoints.

The section headings used herein are for organizational purposes onlyand are not to be construed as limiting the subject matter described.All documents, or portions of documents, cited in this application,including but not limited to patents, patent applications, articles,books, and treatises, are hereby expressly incorporated by reference intheir entirety for any purpose.

Various human and animal tissues can be used to produce products orcompositions for treating patients. For example, various tissue productsfor regeneration, repair, augmentation, reinforcement, and/or treatmentof human tissues that have been damaged or lost due to various diseasesand/or structural damage (e.g., from trauma, surgery, atrophy, and/orlong-term wear and degeneration) have been produced. Such products caninclude, for example, acellular tissue matrices, tissue allografts orxenografts, and/or reconstituted tissues (i.e., at least partiallydecellularized tissues that have been seeded with cells to produceviable materials).

In certain embodiments, these products or compositions can be completelyor partially decellularized to yield acellular tissue matrices orextracellular tissue materials to be used for patients. For example,various tissues, such as skin, intestine, bone, cartilage, nerve tissue(e.g., nerve fibers or dura), tendons, ligaments, or other tissues canbe completely or partially decellularized to produce tissue productsuseful for patients. In some cases, these decellularized products can beused without addition of exogenous cellular materials (e.g., stemcells). In certain cases, these decellularized products can be seededwith cells from autologous sources or other sources to facilitatetreatment. Suitable processes for producing acellular tissue matricesare described below.

Tissue products can be selected to provide a variety of differentbiological and mechanical properties. For example, an acellular tissuematrix or other tissue product can be selected to allow tissue ingrowthand remodeling to assist in regeneration of tissue normally found at thesite where the matrix is implanted. For example, an acellular tissuematrix, when implanted on or into fascia, may be selected to allowregeneration of the fascia without excessive fibrosis or scar formation.In certain embodiments, the tissue product can be formed from ALLODERM®or STRATTICE™, which are human and porcine acellular dermal matrices,respectively. Alternatively, other suitable acellular tissue matricescan be used, as described further below. The methods for shaping tissueshaving an extracellular matrix can be used to process any collagenoustissue type, and for any tissue matrix product. For example, a number ofbiological scaffold materials as described by Badylak et al., or anyother similar materials, can be used to produce tissues with a stablethree-dimensional shape. Badylak et al., “Extracellular Matrix as aBiological Scaffold Material: Structure and Function,” ActaBiomaterialia (2008), doi:10.1016/j.actbio.2008.09.013. In certainembodiments, the compositions discussed herein can be formed from or caninclude a tissue product, a synthetic material, or both.

The term “acellular tissue matrix,” as used herein, refers generally toany tissue matrix that is substantially free of cells and/or cellularcomponents. Skin, parts of skin (e.g., dermis), and other tissues suchas blood vessels, heart valves, fascia, cartilage, bone, and nerveconnective tissue may be used to create acellular matrices within thescope of the present disclosure. Acellular tissue matrices can be testedor evaluated to determine if they are substantially free of cell and/orcellular components in a number of ways. For example, processed tissuescan be inspected with light microscopy to determine if cells (live ordead) and/or cellular components remain. In addition, certain assays canbe used to identify the presence of cells or cellular components. Forexample, DNA or other nucleic acid assays can be used to quantifyremaining nuclear materials within the tissue matrices. Generally, theabsence of remaining DNA or other nucleic acids will be indicative ofcomplete decellularization (i.e., removal of cells and/or cellularcomponents). Finally, other assays that identify cell-specificcomponents (e.g., surface antigens) can be used to determine if thetissue matrices are acellular.

In general, the steps involved in the production of an acellular tissuematrix include harvesting the tissue from a donor (e.g., a human cadaveror animal source) and cell removal under conditions that preservebiological and structural function. In certain embodiments, the processincludes chemical treatment to stabilize the tissue and avoidbiochemical and structural degradation together with or before cellremoval. In various embodiments, the stabilizing solution arrests andprevents osmotic, hypoxic, autolytic, and proteolytic degradation,protects against microbial contamination, and reduces mechanical damagethat can occur with tissues that contain, for example, smooth musclecomponents (e.g., blood vessels). The stabilizing solution may containan appropriate buffer, one or more antioxidants, one or more oncoticagents, one or more antibiotics, one or more protease inhibitors, and/orone or more smooth muscle relaxants.

While an acellular tissue matrix may be made from one or moreindividuals of the same species as the recipient of the acellular tissuematrix graft, this is not necessarily the case. Thus, for example, anacellular tissue matrix may be made from porcine tissue and implanted ina human patient. Species that can serve as recipients of acellulartissue matrix and donors of tissues or organs for the production of theacellular tissue matrix include, without limitation, mammals, such ashumans, nonhuman primates (e.g., monkeys, baboons, or chimpanzees),pigs, cows, horses, goats, sheep, dogs, cats, rabbits, guinea pigs,gerbils, hamsters, rats, or mice.

The compositions discussed herein can be implemented to cover an implantor tissue expander prior to sub-glandular implantation of the implant ortissue expander to reduce or prevent palpability of ripples and/orcapsular contracture. Although discussed herein with respect tosub-glandular reconstruction and augmentation procedures, it should beunderstood that the disclosed compositions can be implemented foralternative medical procedures involving a variety of implants. Coveringthe implant or tissue expander with the composition allows for asmoother operation and improved healing by reducing any reactions fromimplanting a foreign element into the human body.

The compositions can include one or more mesh patterns formed in thecomposition body that facilitate stretching and expanding of thecomposition to wrap around the implant or tissue expander, whileproviding the necessary coverage and support to the implant or tissueexpander. In particular, the mesh patterns reduce the amount of tissueor material that must be used to form the composition, thereby reducingthe cost of preparing the material.

In addition, the stretchable or expandable property of the compositiondue to the mesh patterns allows the composition to conform to the sizeof the implant or tissue expander without the need to trim and discardexcess tissue. Smaller amounts of tissue can therefore be used to coverthe implant or tissue expander without the need for trimming thecomposition. As such, the disclosed compositions reduce waste ofexpensive tissue materials that form the compositions.

In the stretched and expanded configuration, the mesh patterns formperforations through the body of the composition, thereby exposingportions of the implant or tissue expander. However, it is noted thatthe exposure of the implant or tissue expander through the perforationsor openings of the mesh pattern still permits the compositions toprovide the necessary coverage to the implant or tissue expander toreduce or prevent undesired reactions between the breast tissue and theimplant or tissue expander.

In certain embodiments, the composition can be formed from an acellulardermal matrix (ADM) configured to provide full coverage (e.g.,substantially full coverage due to the mesh patterns) to the implant ortissue expander. In certain embodiments, the composition can be formedfrom a synthetic material. In certain embodiments, the composition canbe formed from a combination of ADM and synthetic materials. Thecomposition can provide tissue to camouflage the implant or tissueexpander to decrease palpability of ripples, provide a natural tissuebarrier between the implant or tissue expander and the breast tissueflap, and shield the implant or tissue expander from puncture duringadjust fat transfer or other medical techniques.

The mesh patterns can be designed to optimize coverage of thecomposition relative to the implant or tissue expander, minimize thetotal square area of the tissue composition, and maintain beneficialregenerative properties of the tissue composition post-implantation.Because the composition serves as coverage over the implant or tissueexpander and a barrier between the host tissue and the implant or tissueexpander, the mesh patterns are configured to provide sufficientcoverage to both mask the implant or tissue expander, as well as preventformation of a continuous capsule.

The geometry of the composition can conform to the three-dimensionalshape of the breast pocket and tissue expander. In particular, the meshpatterns allow the composition to stretch and expand in the appropriateregions to conform to the geometry of the implant or tissue expander tobe positioned into the breast pocket.

Adjunct fat injection techniques are generally used on an upper pole ofthe breast. Therefore, in certain embodiments, rather than a meshpattern, a continuous matrix structure can be maintained at the upperpole region of the composition to provide protection from medicaldevices used during the adjunct fat injection technique.

The compositions can include geometries with fastening elements orfeatures that allow for fixation of the composition to the implant ortissue expander. In certain embodiments, the composition can include oneor more flaps that fit into and through the perforations created by themesh pattern in the composition. In certain embodiments, a singlecontinuous sheet or piece of ADM can be wrapped around the implant ortissue expander and attached to the implant or tissue expander byfeeding the flaps into the perforations and fixating the flaps withsuture.

In certain embodiments, the composition can include two separate piecesor sheets of ADM, e.g., a first composition half and a secondcomposition half. The first composition half can include one or moremesh patterns, e.g., at the lower pole, and can be configured to coverthe posterior portion of the implant or tissue expander. The secondcomposition half can include flaps located on and extending from bothupper and lower poles that are designed for passage through the meshpattern and suture fixation to the meshed areas of the posterior piece,e.g., the first composition half. The second composition half cantherefore cover and provide the necessary support to the anteriorportion of the implant or tissue expander, while interlocking with thefirst composition half to maintain the composition wrapped around theimplant or tissue expander.

In certain embodiments, the fastening elements in the form of one ormore individual tissue straps can be used to connect portions of thecomposition to maintain the composition wrapped around the implant ortissue expander. In certain embodiments, the tissue straps can be usedto connect the meshed portions of the composition. The tissue straps caninclude a slit or opening on a proximal end and suture holes on a distalend. The distal end of the tissue strap can be snaked or passed througha perforation of the mesh pattern and then through the slit at theproximal end for fixation of one side of the composition. The distal endcan further be snaked or passed through a perforation of the meshpattern on an opposing side of the composition and sutured to the tissuestrap through a suture hole.

In certain embodiments, the composition can include one or morecontinuous tissue straps formed directly in the composition body thatare designed to wrap around portions of the implant or tissue expanderand/or the composition body to hold the implant or tissue expander inplace within the three-dimensional geometry of the composition duringthe implantation procedure. The tissues traps can therefore maintain thecomposition wrapped around the implant or tissue expander. The tissuestraps can be cut directly into the geometry of the composition andcreate a fixation mechanism that is continuous with the composition anddoes not require suturing.

The compositions discussed herein advantageously provide full tissuecoverage to an implant or tissue expander that can be implanted, e.g.,sub-glandularly, or the like. Fully covering the implant or tissueexpander lowers the risk of capsular contracture and provides a softtissue barrier to mask the implant or tissue expander. The mesh patternsof the compositions decrease costs associated with creating thecompositions. The fastening elements of the compositions can increasethe ease of performing the implantation procedure due to a reduction insuturing. The compositions therefore improve the sub-glandularreconstruction or augmentation procedure by creating a more predictable,aesthetic and biologic outcome and simplifies the overall implantationprocedure.

With reference to FIGS. 1 and 2, one embodiment of an implant 10 (e.g.,a breast implant or tissue expander) is provided. In certainembodiments, the implant 10 can be any type of breast implant, such as abreast implant including a saline solution, a silicone gel, or acomposite filler material. In certain embodiments, the implant 10 can beany type of tissue expander, such as a tissue expander including aninflatable balloon device. In certain embodiments, the implant 10 can beany type of implant and should not be limited to breast implants.

The implant 10 can include a moldable body 12 that can be shaped by asurgeon during the implantation procedure or can be shaped prior to theimplantation procedure. As diagrammatically illustrated in FIGS. 1 and2, the implant 10 can define an upper pole 14 and a lower pole 16separated by an axis 18. The implant 10 can also define a right side 20and a left side 22 separated by an axis 24. The implant can furtherdefine an anterior side 26 and a posterior side 28 separated by an axis30.

During sub-glandular breast reconstruction, the implant 10 can beimplanted between the pectoral muscles and the breast tissue of thepatient. Although the compositions discussed herein cover orsubstantially cover the entire surface area of the implant 10, the lowerpole 16 and/or the right and left sides 20, 22 may require the mostsupport post-implantation. As such, in certain embodiments, the portionsof the composition covering the lower pole 16 and/or the right and leftsides 20, 22 can define a continuous structure (e.g., without meshpatterns), while the remaining portions of the composition include meshpatterns formed therein. In certain embodiments, the portions of thecomposition covering the anterior side 26 can define a continuousstructure, while the remaining portions of the composition include meshpatterns formed therein.

Similarly, adjunct fat injection techniques may be used on the upperpole 14 of the breast. Therefore, in certain embodiments, rather than amesh pattern, a continuous structure can be maintained at the upper pole14 region of the composition to provide protection from medical devicesused during the adjunct fat injection technique, while remainingportions of the composition include mesh patterns formed therein.However, it should be understood that a variety of configurationsincluding continuous structures and mesh patterns are contemplated toprovide adequate support to regions of the implant 10 during andpost-implantation.

With reference to FIG. 3, a front view of one embodiment of an exemplarycomposition 100 is shown. In certain embodiments, the composition 100can be made from processed tissue, e.g., an acellular tissue matrix, anacellular dermal matrix, or the like. In certain embodiments, thecomposition 100 can be made from a synthetic material. In certainembodiments, the composition 100 can be made from a combination ofprocessed tissue and synthetic materials.

The composition 100 includes a composition body 102. The compositionbody 102 can be shaped or formed into a substantially flat or sheet-likeconfiguration. However, the composition body 102 can be flexible suchthat the composition body 102 can conform to and wrap around thethree-dimensional shape of the implant 10. The composition body 102includes a central region 104 from which extensions 106-112 protrude orextend.

The central region 104 can define a substantially rectangularconfiguration. The first extension 106 (e.g., a top extension) and thesecond extension 108 (e.g., a bottom extension) can extend from thecentral region 104 in a substantially parallel manner relative to eachother and a vertical axis 114. The third extension 110 (e.g., a rightextension) and the fourth extension 112 (e.g., a left extension) canextend from the central region 104 in a substantially parallel mannerrelative to each other and a horizontal axis 116. The vertical axis 114can be substantially perpendicular to the horizontal axis 116. As such,the first and second extensions 106, 108 can extend substantiallyperpendicularly relative to the third and fourth extensions 110, 112.

Each of the extensions 106-112 can define a substantially similar width118, length 120, or both. In certain embodiments, one or more of theextensions 106-112 can define a different width 118, length 120, orboth, as compared to the other extensions 106-112. Although illustratedas defining a substantially rectangular configuration, one or more ofthe extensions 106-112 can define, e.g., a square shape, a rectangularshape, an oval shape, or the like. In certain embodiments, the edges ofthe extensions 106-112 can be curved. In certain embodiments, the edgesof the extensions 106-112 can be angled or pointed.

In certain embodiments, the composition 100 can include one or more meshpatterns 122 formed therein. For example, the composition 100 caninclude a mesh pattern 122 formed on a portion or the entire surfacearea of, e.g., the central region 104, the first extension 106, thesecond extension 108, the third extension 110, the fourth extension 112,combinations thereof, or the like. In certain embodiments, the meshpattern 122 can extend from one area of the composition body 102 intoanother area of the composition 102. For example, as shown in FIG. 3,the mesh pattern 122 can extend from the second extension 108 into aportion of the central region 104.

The mesh pattern 122 can include a plurality of slits 124 (e.g.,perforations, openings, or the like) formed in and passing through thecomposition body 102. Portions of the composition body 102 including themesh pattern 122 can be stretched and expanded due to the pattern ofslits 124 such that the length of the portion of the composition body102 can be increased or adjusted based on the size of the implant 10.

In certain embodiments, each slit 124 can be dimensioned equally. Incertain embodiments, the slits 124 can have different dimensions. Incertain embodiments, the slits 124 can be dimensioned betweenapproximately 10 mm to approximately 15 mm in length. In certainembodiments, the slits 124 can be dimensioned between approximately 12mm and approximately 15 mm in length. The slits 124 of the mesh patterns122 formed on the first and second extensions 106, 108 can besubstantially parallel to each other and the horizontal axis 116. Theslits 124 of the mesh patterns 122 formed on the third and fourthextensions 110, 112 can be substantially parallel to each other and thevertical axis 114. In certain embodiments, the slits 124 can be linearin form. In certain embodiments, the slits 124 can be curved in form. Incertain embodiments, each row of slits 124 can be staggered or offsetrelative to the adjacent row of slits 124. In certain embodiments, eachrow of slits 124 can be staggered or offset relative to the adjacent rowof slits 124 by approximately 8 mm to approximately 10 mm. In certainembodiments, each row of slits 124 can be spaced from the adjacent rowof slits 124 by approximately five mm or less. However, it should beunderstood that alternative distance ranges can be used to optimize thesize and/or stretching of the composition 100.

Although illustrated as a plurality of slits, in certain embodiments,the mesh patterns discussed herein can be formed from any pattern ofholes or openings. For example, in certain embodiments, the meshpatterns can be formed from a pattern of circular holes spaced relativeto each other such that the composition can be stretched and expanded atthe mesh patterns. As a further example, in certain embodiments, themesh patterns can be formed from a pattern of oval holes spaced relativeto each other such that the composition can be stretched and expanded atthe mesh patterns.

In certain embodiments, portions of the composition body 102 can definea continuous structure 126 (e.g., a structure without a mesh pattern 122formed therein). Areas with a continuous structure 126 can be alignedwith portions of the implant 10 that require the most amount of supportor protection. The areas of the composition body 102 including the meshpattern 122 and the continuous structure 126 can be customized dependingon the type of implant 10 being used with the composition 100 andcharacteristics of the patient receiving the implant 10. For example, ifa patient is known to have insufficient host tissue for supporting theimplant on certain sides, the composition 100 can be customized todefine a continuous structure 126 on those sides to provide addedsupport to the implant 10. As a further example, the continuousstructure 126 can be located on the area of the composition 100 thatwill be used to provide greater support to the lower pole 16 of theimplant 10, while the mesh patterns 122 are formed to allow theextensions 106-112 to wrap around the remaining areas of the implant 10.

With reference to FIGS. 4 and 5, front and perspective views of oneexemplary embodiment of a fastening element 130 are provided. Thefastening element 130 can be formed from a tissue (e.g., an acellulartissue matrix, an acellular dermal matrix, or the like) and/or asynthetic material. As will be discussed in greater detail below, thefastening element 130 can be used to secure the composition 100 to theimplant 10 in the wrapped configuration. The fastening element 130 canbe in the form of an elongated strap including an elongated body 132with a proximal end 134 and a distal end 136. The width 138 of theelongated body 132 can be dimensioned to pass freely through the slits124 of the mesh patterns 122 formed in the composition 100. Thefastening element 130 can be flexible to allow manipulation of thefastening element 130 when interlocking the fastening element 130relative to components of the composition 100.

The proximal end 134 of the fastening element 130 can include a roundedtip 140. The diameter of the tip 140 can be dimensioned greater than thewidth 138 of the elongated body 138 to accommodate a slit 142 formed inthe proximal end 134. The slit 142 can extend in a perpendiculardirection relative to the elongated body 138 extending from the tip 140.The slit 142 can pass through the tip 140 and provides an aperturethrough which the distal end 136 and the elongated body 132 can pass. Inparticular, the slit 142 can be dimensioned to allow passage of thedistal end 136 and the elongated body 132 therethrough. In certainembodiments, the slit 142 can be dimensioned slightly greater than thewidth 138 of the elongated body 132.

The distal end 136 of the fastening element 130 can define a rounded tip144. The rounded tip 144 can provide an easier configuration for passinginto the slit 142 of the proximal end 134. Starting from a positionspaced from the tip 144, the elongated body 132 can include one or moresuture holes or apertures 146 formed in and passing through theelongated body 132. In certain embodiments, the apertures 146 can beformed from the distal end 136 up to the slit 142 of the proximal end134. In certain embodiments, the apertures 146 can be formed from thedistal end 136 a partial distance in the direction of the slit 142 ofthe proximal end 134. The apertures 146 can be configured anddimensioned to allow suture to be passed therethrough for securing thedistal end 136 to the elongated body 102.

As shown in FIG. 5, during assembly, the distal end 136 of the fasteningelement 130 can initially be snaked or passed through a slit 124 in themesh pattern 122 in the composition 100, and further passed through theslit 142 in the proximal end 134 of the fastening element 130. A firstloop 148 can thereby be formed to secure the fastening element 130 to afirst portion of the composition 100.

The distal end 136 is further snaked or passed through a slit 124 inanother mesh pattern 122 of the composition 100, and folded over toalign two of the apertures 146. A second loop 150 can thereby be formedto secure the fastening element 130 to a second portion of thecomposition 100. The apertures 146 used for alignment to create thesecond loop 150 can be selected based on the desired tension between thefirst and second portions of the composition 100, e.g., the desiredtension to maintain the composition 100 wrapped around the implant 10.In certain embodiments, if insufficient tension is created by thefastening element 130, the fastening element 130 can be passed throughalternative openings 152 in the mesh pattern 122 away from the edge ofthe extension 106-112 such that certain extensions 106-112 overlaprelative to each other to create the desired tension. Suture can bepassed through the aligned apertures 146 to secure the distal end 136 tothe elongated body 132, and to maintain the fastening element 130interlocked relative to the composition 100.

With respect to FIG. 6, a perspective view of the composition 100 beingwrapped around the implant 10 is shown. Initially, the implant 10 can bepositioned on and orientated relative to the composition 100 such thatthe appropriate sections of the implant 10 that require additionalsupport are positioned adjacent to continuous structure 126 portions ofthe composition 100. For example, the lower pole 16 and the anteriorside 26 of the implant 10 can be positioned against continuous structure126 portions of the composition 100. With respect to the lower pole 16,a greater amount of support may be desired due to most of the weight ofthe implant 10 being relayed to the bottom breast tissuepost-implantation.

In the initial configuration, the composition 100 can be dimensionedsmaller than the surface area of the implant 10. However, as shown inFIG. 6, one or more extensions 106-112 can include mesh patterns 122 forexpanding and stretching portions of the composition 100 to wrap thecomposition 100 around the implant 10 (e.g., to completely or nearlycompletely surround the implant 10). As discussed herein, completely ornearly completely surrounding, covering or wrapping the implant 10indicates that the composition 100 stretches or expands over a majorportion of the surface area of the implant 10. Thus, although thecomposition 100 includes mesh patterns 122 that stretch and expand tocreate openings exposing portions of the implant 10 therethrough, itshould be understood that the composition 100 is still considered assurrounding, covering or wrapping the implant 10.

For example, the third and fourth extensions 110, 112 are shownstretched in FIG. 6 to wrap around the right side 20, left side 22 andposterior side 28 of the implant 10. The mesh patterns 122 can beexpanded and stretched by applying a tensile force on the respectiveextension 106-112 associated with the mesh pattern 122. The slits 124that form the mesh pattern 122 can expand due to the tensile force tocreate a plurality of openings 152 that are dimensioned greater than theslits 124 in the non-expanded configuration. The expanded and stretchedmesh patterns 122 allow the composition 100 to conform to the sizeand/or shape of the implant 10. As such, less material is necessary towrap the composition 100 nearly completely or completely around theimplant 10.

In order to secure portions of the composition 100 around the implant 10in a wrapped configuration, one or more fastening elements 130 can beused. As discussed above, the distal end 136 of the fastening element130 can be passed through an opening 152 (e.g., the opening 152 in thefourth extension 112) and further passed through the slit 142 formed inthe proximal end 134 of the fastening element 130. The first loop 148formed at the proximal end 134 of the fastening element 130 can therebybe passed around and interlocked with a strip 154 of materialsurrounding the opening 152 and, thereby, the fourth extension 112.

The distal end 136 can further be passed through the opening 152 in adifferent mesh pattern 122 (e.g., the opening 152 in the third extension110). In certain embodiments, the second loop 150 can be formed around amesh pattern 122 in an extension 106-112 opposing the extension 106-112around which the first loop 148 is formed. After passing the distal end136 through the opening 152, the fastening element 130 can be used totighten the first and second extensions 110, 112 relative to each otheruntil the desired amount of wrapping of the composition 100 around theimplant is achieved. In certain embodiments, the third and fourthextensions 110, 112 can be stretched until the third and fourthextensions 110, 112 are in a touching relation, thereby wrapping aroundthe entire posterior side 28 of the implant 10. In certain embodiments,the third and fourth extensions 110, 112 can be stretched and remain ina spaced relation relative to each other, thereby leaving a portion ofthe posterior side 28 of the implant 10 exposed. However, in suchembodiments, support to the implant 10 can naturally be provided by thechest wall and/or the pectoral muscle against which the implant 10 ispositioned. Thus, the composition 100 completely or nearly completelysurrounds the surface area of the implant 10.

The distal end 136 can be folded over the strip 156 of materialsurrounding the opening 152 and two apertures 146 in the fasteningelement 130 can be aligned. Suture 158 can be passed through theapertures 146 to secure the second loop 150 around the strip 156,thereby interlocking the fastening element 130 to the third extension110. In certain embodiments, suture 158 can be passed through theelongated body 132 without the use of the apertures 146. The fasteningelement 130 therefore stretches between the third and fourth extensions110, 112 and around a portion of the implant 10. The fastening element130 can thereby maintain the third and fourth extensions 110, 112wrapped around the implant 10. In certain embodiments, suture can beused to secure the extensions 106-112 relative to each other.

With respect to FIG. 7, a perspective view of the composition 100 beingwrapped around the implant 10 is shown. The composition 100 can bewrapped completely or nearly completely around the implant 10 in asubstantially similar manner to that described with respect to FIG. 6.However, rather than using a single fastening element 130, two or morefastening elements 130 can be used to secure the opposing extensions106-112 relative to each other. For example, a first fastening element130 can be used to secure the first and second extensions 106, 108relative to each other, and a second fastening element 130 can be usedto secure the third and fourth extensions 110, 112 relative to eachother. It should be understood that any number of fastening elements 130can be used to secure the composition 100 in a wrapped configurationaround the implant 10.

In certain embodiments, one fastening element 130 can be used to securethree or more extensions 106-112 relative to each other. For example,after the fastening element 130 has been interlocked relative to oneextension, e.g., the first extension 106, the distal end can be passedthrough the openings of the third, second and fourth extensions 110,106, 112 and interlocked relative to the fourth extension 112. A singlefastening element 130 can thereby be used to maintain each extension106-112 wrapped around the implant 10.

With reference to FIGS. 8 and 9, front and perspective views of anotherexemplary embodiment of a fastening element 160 are provided. Thefastening element 160 can be formed from a tissue (e.g., an acellulartissue matrix, an acellular dermal matrix, or the like) and/or asynthetic material. As will be discussed in greater detail below, thefastening element 160 can be used to secure the composition 100 to theimplant 10 in the wrapped configuration.

The fastening element 160 can be in the form of a substantially T-shapedstrap including a vertical elongated body 162, a first horizontalelongated body 164, and a second horizontal elongated body 166. Thevertical elongated body 162 can define a proximal end 168 and a distalend 170. The first and second horizontal elongated bodies 164, 166 canextend in a substantially parallel manner relative to each other fromopposing sides of the proximal end 168 of the vertical elongated body162. In particular, the first and second horizontal elongated bodies164, 166 can extend in a substantially perpendicular manner relative tothe vertical elongated body 162.

The first horizontal elongated body 164 can define a proximal end 172and a distal end 174. The proximal end 172 of the first horizontalelongated body 164 can be formed integrally with the proximal end 168 ofthe vertical elongated body 162. The first horizontal elongated body 164thereby connects to the vertical elongated body 162 at the proximal end172. The second horizontal elongated body 166 can define a proximal end176 and a distal end 178. The proximal end 178 of the second horizontalelongated body 166 can be formed integrally with the proximal end 168 ofthe vertical elongated body 162. The second horizontal elongated body166 thereby connects to the vertical elongated body 162 at the proximalend 176.

The vertical elongated body 162 and the first and second horizontalelongated bodies 164, 166 can define widths 180-184, respectively, canbe dimensioned to pass freely through the slits 124 of the mesh patterns122 formed in the composition 100. The fastening element 160 can beflexible to allow manipulation of the fastening element 160 wheninterlocking the fastening element 160 relative to components of thecomposition 100.

In certain embodiments, the proximal end 168 of the vertical elongatedbody 162 can include a rounded tip 186. The diameter of the rounded tip186 can be dimensioned greater than the width 180 of the verticalelongated body 162 to provide a stronger structure for attachment of thefirst and second horizontal elongated bodies 164, 166. The rounded tip186 can accommodate a slit 188 formed in the proximal end 168. The slit188 can extend in a perpendicular direction relative to the verticalelongated body 162 extending from the tip 186 and substantially parallelto the first and second horizontal elongated bodies 164, 166. The slit188 can pass through the tip 186 and provides an aperture through whichthe distal end 170 and the vertical elongated body 162 can pass. Inparticular, the slit 188 can be dimensioned to allow passage of thedistal end 170 and the vertical elongated body 162 therethrough. Incertain embodiments, the slit 188 can be dimensioned slightly greaterthan the width 180 of the vertical elongated body 162.

The distal end 170 of the vertical elongated body 162 can define arounded tip 190. The rounded tip 190 can provide an easier configurationfor passing into the slit 188 of the proximal end 168. Starting from aposition spaced from the tip 190, the vertical elongated body 162 caninclude one or more suture holes or apertures 192 formed in and passingthrough the vertical elongated body 162. In certain embodiments, theapertures 192 can be formed from the distal end 170 up to the slit 188of the proximal end 168. In certain embodiments, the apertures 192 canbe formed from the distal end 170 a partial distance in the direction ofthe slit 188 of the proximal end 168. The apertures 192 can beconfigured and dimensioned to allow suture therethrough for securing thedistal end 170 to the vertical elongated body 162.

In certain embodiments, the distal end 174 of the first horizontalelongated body 164 can include a rounded tip 194. The diameter of therounded tip 194 can be dimensioned greater than the width 182 of thefirst horizontal elongated body 164. The rounded tip 194 can accommodatea slit 196 formed in the distal end 174. The slit 196 can extend in aperpendicular direction relative to the first horizontal elongated body164 extending from the tip 194 and substantially parallel to thevertical elongated body 162. The slit 196 can pass through the tip 194and is dimensioned to provide an aperture through which the verticalelongated body 162, the second horizontal elongated body 166, and thefirst horizontal elongated body 164 can pass. As will be discussed ingreater detail below, the flexibility of the fastening element 160allows portions of the fastening element 160 to be folded and passedthrough the slit 196.

The proximal end 172 of the first horizontal elongated body 164 can beconnected to the proximal end 168 of the vertical elongated body 162.Other than the slit 196, the first horizontal elongated body 164 candefine a continuous and aperture-free material.

The proximal end 176 of the second horizontal elongated body 166 can beconnected to the proximal end 168 of the vertical elongated body 162.The distal end 178 of the second horizontal elongated body 166 candefine a rounded tip 198. The rounded tip 198 can provide an easierconfiguration for passing into the slit 198 of the distal end 174 of thefirst horizontal elongated body 164. Starting from a position spacedfrom the tip 198, the second horizontal elongated body 166 can includeone or more suture holes or apertures 200 formed in and passing throughthe second horizontal elongated body 166. In certain embodiments, theapertures 200 can be formed from the distal end 178 up to the slit 188of the proximal end 168 of the vertical elongated body 162. In certainembodiments, the apertures 200 can be formed from the distal end 178 apartial distance in the direction of the slit 188 of the proximal end168 of the vertical elongated body 162. The apertures 200 can beconfigured and dimensioned to allow suture therethrough for securing thedistal end 178 to the second horizontal elongated body 166.

As shown in FIG. 9, during assembly, distal end 174 of the firsthorizontal elongated body 164 can initially be snaked or passed througha slit 124 in the mesh pattern 122 in the composition 100. The verticalelongated body 162 and the second horizontal elongated body 166 can thenbe snaked or passed through the slit 196 of the distal end 174. Forexample, the vertical elongated body 162 can be folded onto the secondhorizontal elongated body 166 (e.g., to substantially align the distalends 170, 178) and the distal ends 170, 178 can be snaked or passedthrough the slit 196. A first loop 202 can thereby be formed to securethe fastening element 160 to a first portion of the composition 100(e.g., a fourth extension 112).

Next, the distal end 170 of the vertical elongated body 162 can besnaked or passed through a slit 124 in another mesh pattern 122 in thecomposition (e.g., the second extension 108). The distal end 170 of thevertical elongated body 162 can further be snaked or passed through theslit 188 of the vertical elongated body 162. A second loop 204 canthereby be formed to secure the fastening element 160 to a secondportion of the composition 100 (e.g., the second extension 108).

Next, the distal end 170 of the vertical elongated body 162 can besnaked or passed through a slit 124 in another mesh pattern 122 of thecomposition 100 (e.g., the first extension 106), and folded over toalign two of the apertures 192. A third loop 206 can thereby be formedto secure the fastening element 160 to a third portion of thecomposition 100 (e.g., the first extension 106). The apertures 192 usedfor alignment to create the third loop 206 can be selected based on thedesired tension between the second and third portions of the composition100, e.g., the desired tension to maintain the second and third portionsof the composition 100 wrapped around the implant 10. Suture can bepassed through the aligned apertures 192 to secure the distal end 170 tothe vertical elongated body 162, and to maintain the fastening element160 interlocked relative to the third portion of the composition 100.

As a final step, the distal end 178 of the second horizontal elongatedbody 166 can be snaked or passed through a slit 124 in another meshpattern 122 of the composition 100 (e.g., the third extension 110), andfolded over to align two of the apertures 200. A fourth loop 208 canthereby be formed to secure the fastening element 160 to a fourthportion of the composition 100 (e.g., the third extension 110). Theapertures 200 used for alignment to create the fourth loop 208 can beselected based on the desired tension between the first and fourthportions of the composition 100, e.g., the desired tension to maintainthe first and fourth portions of the composition 100 warped around theimplant 10. In certain embodiments, if insufficient tension is createdby the fastening element 160, the fastening element 160 can be passedthrough alternative openings 152 in the mesh pattern 122 away from theedge of the extension 106-112 such that certain extensions 106-112overlap relative to each other to create the desired tension. Suture canbe passed through the aligned apertures 200 to secure the distal end 178to the second horizontal elongated body 166, and to maintain thefastening element 160 interlocked relative to the fourth portion of thecomposition 100.

With respect to FIG. 10, a perspective view of the composition 100 beingwrapped around the implant 10 is shown. Positioning and orientation ofthe implant 10 relative to the composition 100 can be substantiallysimilar to the process described with respect to FIG. 6. However, ratherthan using one or two fastening elements 130 to secure portions of thecomposition 100 around the implant 10 in a wrapped configuration, asingle fastening element 160 can be used to secure all four extensions106-112 relative to each other.

As described above, the fastening element 160 can be used to createloops 202-208 to interlock the fastening element 160 relative torespective extensions 106-112 of the composition 100. For example, thefirst loop 202 can be formed relative to the opening 152 and the strip210 of material surrounding the opening 152 in the fourth extension 112.The second loop 204 can be formed relative to the opening 152 and thestrip 212 of material surrounding the opening 152 in the secondextension 108. The third loop 206 can be formed relative to the opening152 and the strip 214 of material surrounding the opening 152 in thefirst extension 106. The fourth loop 208 can be formed relative to theopening 152 and the strip 216 of material surrounding the opening 152 inthe third extension 110. However, it should be understood that thefastening element 160 can be orientated differently relative to thecomposition 100 such that loops 202-208 are used to secure the fasteningelement 160 to alternative extensions 106-112. Suture 158 can be passedthrough the apertures 192, 200 to secure the loops 206, 208 around thestrips 214, 216, respectively, thereby interlocking the fasteningelement 160 to two of the extensions 106-112. In certain embodiments,suture 158 can be passed through the elongated body 162, 166 without theuse of the apertures 192, 200.

The vertical elongated body 162 can therefore be used to secure twoportions of the composition 100 (e.g., the first and second extensions106, 108) relative to each other and in the wrapped configuration aroundthe implant 10. In particular, the passage of the distal end 170 of thevertical elongated body 162 through the opening 152 in the firstextension 106 can be varied to increase or decrease the tension anddistance between the first and second extensions 106, 108, therebyallowing adjustment of the amount of surface area of the implant 10wrapped by the composition 100.

The first and second horizontal elongated bodies 164, 166 can be used tosecure two alternative portions of the composition 100 (e.g., the thirdand fourth extensions 110, 112) relative to each other and in thewrapped configuration around the implant 10. In particular, the passageof the distal end 178 of the second horizontal elongated body 166through the opening 152 in the fourth extension 112 can be varied toincrease or decrease the tension and distance between the third andfourth extensions 110, 112, thereby allowing adjustment of the amount ofsurface area of the implant 10 wrapped by the composition 100.

In certain embodiments, the extensions 106-112 can be stretched untilthe two or more of the extensions 106-112 are in a touching relation,thereby wrapping around the entire posterior side 28 of the implant 10.In certain embodiments, the two or more of the extensions 106-112 can bestretched and remain in a spaced relation relative to each other,thereby leaving a portion of the posterior side 28 of the implant 10exposed. However, in such embodiments, support to the implant 10 cannaturally be provided by the chest wall and/or the pectoral muscleagainst which the implant 10 is positioned. Thus, the composition 100completely or nearly completely surrounds the surface area of theimplant 10.

With reference to FIG. 11, a front view of another embodiment of anexemplary composition 300 is shown. In certain embodiments, thecomposition 300 can be made from processed tissue, e.g., an acellulartissue matrix, an acellular dermal matrix, or the like. In certainembodiments, the composition 300 can be made from a synthetic material.In certain embodiments, the composition 300 can be made from acombination of processed tissue and synthetic materials.

The composition 300 includes a composition body 302. The compositionbody 302 can be shaped or formed into a substantially flat or sheet-likeconfiguration. However, the composition body 302 can be flexible suchthat the composition body 302 can conform to and wrap around thethree-dimensional shape of the implant 10.

The composition body 302 includes a top region 304, a bottom region 306,and a central region 308 disposed between the top and bottom regions304, 306. The top region 304 can define a substantially semi-circularform 310 extending from the central region 308. The bottom region 306can define a substantially semi-circular form 312 extending from anopposing side of the central region 308 relative to the top region 304.The central region 308 includes a first flap 314 and a second flat 316extending therefrom on opposing sides of the central region 308. Incertain embodiments, the first and second flaps 314, 316 can definepointed ends with curved sides. In certain embodiments, the first andsecond flaps 314, 316 can define pointed ends with linear sides.

In certain embodiments, the top region 304 can include two groups 318,320 of apertures formed therein. The groups 318, 320 of apertures can beformed on opposing sides of the top region 304 in a spaced manner. Eachgroup 318, 320 can include a first pair of apertures 322 and a secondpair of apertures 324. The first and second pair of apertures 322, 324can be positioned on opposing sides of a fold line 326. In certainembodiments, the fold line 326 can be formed in the composition body 302to assist in folding the top region 304 over the implant 10. In certainembodiments, the composition body 302 does not include a fold line 326and the fold line 326 shown in FIG. 11 is provided for illustrativepurposes only.

The first pair of apertures 322 includes a first aperture 328 and asecond aperture 330. The second pair of apertures 324 includes a firstaperture 332 and a second aperture 334. The first and second pair ofapertures 322, 324 can be disposed on opposing sides of the fold line326 such that when the top region 304 is folded along the fold line 326,the first apertures 328, 332 and the second apertures 330, 334 align forsuture passage therethrough. Thus, in embodiments including a fold line326 formed in the composition body 302, the fold line 326 can assistwith aligning the first and second pair of apertures 322, 324 relativeto each other.

In certain embodiments, the bottom region 306 can include one or morestraps formed therein, e.g., a first strap 336 and a second strap 338.In particular, the first and second straps 336, 338 can be formeddirectly in the composition body 302. For example, the first strap 336can be formed from material directly adjacent to the semi-circular form312 and the second strap 338 can be formed from material directlyadjacent to the first strap 336. The straps 336, 338 can thereforeextend from one edge to the opposite edge of the bottom region 306spanning the width of the bottom region 306. In certain embodiments, thecomposition 300 can include one or more straps formed adjacent to thetop region 304.

Each strap 336, 338 can define an elongated body that can be configuredand dimensioned to be extended over portions of the implant 10 tomaintain the composition 300 in a wrapped configuration relative to theimplant 10. In particular, the straps 336, 338 can be stretched and fitover portions of the implant 10, and the flexible material of thecomposition 300 allows the straps 336, 338 to stay in place and maintaina pressure on the implant 10 sufficient to prevent undesired unwrappingof the composition 300. For example, the first strap 336 can be used toextend onto the upper pole 14 of the implant 10. As a further example,the second strap 338 can be used to extend onto the lower pole 16 of theimplant 10.

Although illustrated with two straps 336, 338, in certain embodiments,the composition 300 can include a single strap (e.g., strap 336) thatcan sufficiently maintain the composition 300 wrapped around the implant10. In certain embodiments, the composition 300 can include two or morestraps that provide an even distribution of tension on the implant 10 tomaintain the composition 300 in a wrapped configuration . . . .

In certain embodiments, one or more portions or areas of the composition300 can include a mesh pattern 340 formed therein. As shown in FIG. 11,in certain embodiments, the bottom region 306 can include a mesh pattern340 formed on all or a portion of the surface area thereof. In certainembodiments, the mesh pattern 340 can be formed on all or a portion ofthe surface area of, e.g., the top region 304, the central region 308,the bottom region 306, the first flap 314, the second flap 316,combinations thereof, or the like. In certain embodiments, the meshpattern 340 can extend from one area into another area of thecomposition body 302. The location or formation of the mesh pattern 340can be selected based on the areas of the implant 10 that require themost and least support. For example, areas of the implant 10 requiringless support can be covered by portions of the composition 300 includingthe mesh pattern 340, while areas of the implant 10 requiring moresupport can be covered by portions of the composition 300 including thecontinuous structure (e.g., without a mesh pattern 340, such as thecentral region 308 of FIG. 11).

The mesh pattern 340 can be substantially similar to the mesh pattern122 discussed above. In particular, the mesh pattern 340 can include aplurality of slits 342. In certain embodiments, the slits 342 can beformed in a horizontal direction. In certain embodiments, the slits 342can be formed in a vertical direction. In certain embodiments, each rowof adjacent slits 342 can be staggered relative to each other. Impartinga tensile force on any portions of the composition 300 including themesh pattern 340 allows the composition body 302 to stretch and expandto cover the three-dimensional form of the implant 10.

With respect to FIGS. 12 and 13, side and rear views of the composition300 completely or nearly completely wrapped around the implant 10 areshown. Initially, the implant 10 can be positioned on and orientedrelative to the composition 300 such that the appropriate sections ofthe implant 10 that require additional support are positioned adjacentto continuous structure portions of the composition 300. For example, asshown in FIGS. 12 and 13, the lower pole 16 of the implant 10 can bepositioned at or near the mesh pattern 340 of the bottom region 306 ofthe composition 300, while the upper pole 14 of the implant 10 can bepositioned at or near the top and central regions 304, 308 of thecomposition 300 defining the continuous structure. However, it should beunderstood that the implant 10 can be oriented in other ways relative tothe composition 300 and/or the composition 300 can include alternativeor additional areas including the mesh pattern 340.

In the initial configuration, the composition 300 can be dimensionedsmaller than the surface area of the implant 10. However, as shown inFIGS. 12 and 13, one or more areas of the composition body 302 includingthe mesh patterns 340 can be expanded and stretched to at leastpartially wrap the composition 300 around the implant 10. For example,the bottom region 306 of the composition 300 can be expanded andstretched to wrap around the lower pole 16 of the implant 10. The meshpattern 340 can be expanded and stretched by applying a tensile force onthe bottom region 306. The slits 342 that form the mesh pattern 340 canexpand due to the tensile force to create a plurality of openings 344that are dimensioned greater than the slits 342 in the non-expandedconfiguration. In particular, due to the flexibility of the mesh pattern340, the expansion and stretching of the mesh pattern 340 can becustomized based on the particular implant 10 configuration being used.Thus, less material can be used to completely or nearly completely wrapthe composition 300 around a variety of implants 10.

During the wrapping process, the top region 304 can be folded along thefold line 326 to align the respective first pair of apertures 322 withthe second pair of apertures 324. In certain embodiments, suture 346 canbe passed through the apertures 322, 324 to maintain the top region 304in the folded configuration. In the folded configuration, the top region304 can form a first flap 348 and a second flap 350. The first andsecond flaps 348, 350 can extend outwardly from the surface of theimplant 10.

The first and second flaps 314, 316 extending from the central region308 can be wrapped around portions of the respective right and leftsides 20, 22 of the implant 10. The bottom region 306 can be stretchedover the lower pole 16 of the implant 10. Thus, in the wrappedconfiguration, the top region 304, bottom region 306, first flap 314 andsecond flap 316 can join in a facing, spaced or overlapping manner atthe posterior side 28 of the implant 10.

In certain embodiments, to maintain the composition 300 in the wrappedconfiguration, the first strap 336 can be pulled and stretched upwardand disposed around an edge of the top region 304 (e.g., FIG. 12). Incertain embodiments, to maintain the composition 300 in the wrappedconfiguration, the first strap 336 can be pulled and stretched upwardand disposed around the first and second flaps 348, 350 of the topregion 304 (e.g., FIG. 13). In particular, the first strap 336 can fitbetween the first and second flaps 348, 350 and the implant 10 and/orthe first and second flaps 314, 316 to maintain the first strap 336interlocked relative to the top region 304. Specifically, the edges ofthe first and second flaps 348, 350 prevent the first strap 336 fromreturning to a position adjacent to the bottom region 306. Stretchingthe first strap 336 from the bottom region 306 to the top region 304creates tension in the first strap 336, thereby maintaining a tight gripon the first and second flaps 348, 350. The tension in the first strap336 also maintains the top region 304 wrapped around the implant 10.

Portions of the first strap 336 can pass over the first and second flaps314, 316, thereby also maintaining the first and second flaps 314, 316wrapped around the implant 10. The second strap 338 can be stretched andwrapped around a portion of the bottom region 306. The tension in thesecond strap 338 maintains pressure on the bottom region 306, therebyensuring that the bottom region 306 remains wrapped around the implant10. As such, the first and second straps 336, 338 assist in maintainingthe composition 300 completely or nearly completely wrapped around theimplant 10.

With reference to FIG. 14, a front view of another embodiment of anexemplary composition 400 is shown. In certain embodiments, thecomposition 400 can be made from processed tissue, e.g., an acellulartissue matrix, an acellular dermal matrix, or the like. In certainembodiments, the composition 400 can be made from a synthetic material.In certain embodiments, the composition 400 can be made from acombination of processed tissue and synthetic materials.

The composition 400 includes a composition body 402 formed as a singlepiece of material. The composition body 402 can be shaped or formed intoa substantially flat or sheet-like configuration. However, thecomposition body 402 can be flexible such that the composition body 402can conform to or wrap around the three-dimensional shape of the implant10.

In certain embodiments, the composition body 402 can define, e.g., arectangular shape, a square shape, an oval shape, a circular shape, orthe like. The composition 400 can include two or more tabs or flaps 404,406 extending from one end of the composition body 402. For example, theflaps 404, 406 can extend from the bottom edge of the composition body402. In certain embodiments, the composition 400 can include flaps 404,406 extending from the bottom and/or side edges of the composition body402.

In certain embodiments, the composition 400 can include one or more meshpatterns 408 formed therein. The mesh patterns 408 can be formed from aplurality of slits 410 formed in and passing through the compositionbody 402. In certain embodiments, the slits 410 can be formed in ahorizontal direction. In certain embodiments, the slits 410 can beformed in a vertical direction. In certain embodiments, adjacent rows ofslits 410 can be staggered or offset relative to each other. In certainembodiments, the slits 410 can be linear, angled, a combination thereof,or the like. Each slit 410 can be configured and dimensioned to allowpassage of a single flap 404, 406 therethrough. As described above, themesh patterns 408 allow portions of the composition body 402 to beexpanded and stretched to conform the composition body 402 to thethree-dimensional shape of the implant 10, thereby allowing the implant10 to be at least partially wrapped with the composition 400.

With reference to FIG. 15, a perspective view of the composition 400completely or nearly completely wrapped around the implant 10 isprovided. Initially, the implant 10 can be positioned on or orientedrelative to the composition 400 such that the appropriate sections ofthe implant 10 that require additional support are positioned adjacentto continuous structure portions of the composition 400 (e.g., areaswithout the mesh pattern 408). In the initial configuration, thecomposition 400 can be dimensioned smaller than the surface area of theimplant 10. However, as shown in FIG. 15, one or more areas of thecomposition body 402 including the mesh patterns 408 can be expanded andstretched to at least partially wrap the composition 400 around theimplant 10. For example, the mesh patterns 408 shown in FIG. 15 can beexpanded or stretched to wrap around portions of the upper and lowerpoles 14, 16 of the implant 10. The mesh pattern 408 can be expanded orstretched by applying a tensile force on the edges of the compositionbody 402. The slits 410 that form the mesh pattern 408 can expand due tothe tensile force to create a plurality of openings that are dimensionedgreater than the slits 410 in the non-expanded configuration. Inparticular, due to the flexibility of the mesh patterns 408, theexpansion and stretching of the mesh patterns 408 can be customizedbased on the particular implant 10 configuration being used. Thus, lessmaterial can be used to wrap the composition 400 around a variety ofimplants 10.

During the wrapping process, the implant 10 can be positioned on andoriented relative to the composition 400. The top and bottom edges ofthe composition 400 can be wrapped around the implant 10 such that thetop and bottom edges meet in a facing relation. As the composition 400is wrapped around the implant 10, the mesh patterns 408 can expand andstretch to conform the composition 400 to the three-dimensional form ofthe implant 10. The flaps 404, 406 can be passed through two slits 410of the mesh pattern 408 near the adjacent edge of the composition body402.

In certain embodiments, suture 412 can be used to secure the flaps 404,406 to the composition body 402 such that the flaps 404, 406 cannot passout of the slits 410. The flaps 404, 406 thereby act as fasteningelements and maintain the composition 400 stretched and wrapped aroundthe implant 10. In certain embodiments, the composition 400 can includetabs extending from side edges of the composition 400 such that thesides of the implant 10 can be fully covered by the composition 400 inthe wrapped configuration.

With reference to FIGS. 16 and 17, front views of another embodiment ofan exemplary composition (e.g., first and second composition halves 500,550) are shown. As will be discussed in greater below, the first andsecond composition halves 500, 550 can mate relative to each other to atwrap around and at least partially cover the implant 10. In certainembodiments, the composition halves 500, 550 can be made from processedtissue, e.g., an acellular tissue matrix, an acellular dermal matrix, orthe like. In certain embodiments, the composition halves 500, 550 can bemade from a synthetic material. In certain embodiments, the compositionhalves 500, 550 can be made from a combination of processed tissue andsynthetic materials.

The first composition half 500 includes a composition body 502. Thecomposition body 502 can be shaped or formed into a substantially flator sheet-like configuration. However, the composition body 502 can beflexible such that the composition body 502 can conform to or wraparound a portion of the three-dimensional shape of the implant 10.

In certain embodiments, the composition body 502 can define, e.g., arectangular shape, a square shape, an oval shape, a circular shape, orthe like. The first composition half 500 can include two or more tabs orflaps 504, 506 extending from a top edge 508 of the composition body502. The first composition half 500 can include two or more tabs orflaps 510, 512 extending from a bottom edge 514 of the composition body502. In particular, the flaps 504, 506 can extend in a parallel mannerrelative to the flaps 510, 512. In certain embodiments, the flaps 504,506 and the flaps 510, 512, respectively, can extend in line or bealigned relative to each other. In certain embodiments, the flaps 504,506, 510, 512 can be formed integrally and from the same material as thecomposition body 502. In certain embodiments, the first composition half500 can include flaps extending from the side edges of the compositionbody 502.

In certain embodiments, the first composition half 500 can include oneor more mesh patterns 516 formed therein. The mesh patterns 516 can beformed from a plurality of slits 518 formed in and passing through thecomposition body 502. In certain embodiments, the slits 518 can beformed in a horizontal direction. In certain embodiments, the slits 518can be formed in a vertical direction. In certain embodiments, adjacentrows of slits 518 can be staggered or offset relative to each other. Incertain embodiments, the slits 518 can be linear, angled, a combinationthereof, or the like. In certain embodiments, the mesh patterns 516 canbe formed in a substantial portion of the composition body 502 (e.g.,areas excluding the flaps 504, 506, 510, 512). In certain embodiments,the mesh patterns 516 can be formed in a central portion of thecomposition body 502 (e.g., leaving portions of the composition body 502as continuous structures). In certain embodiments, the As describedabove, the mesh patterns 516 allow portions of the composition body 502to be expanded and stretched to conform the composition body 502 to thethree-dimensional shape of the implant 10, thereby allowing the implant10 to be at least partially wrapped with the first composition half 500.

The second composition half 550 includes a composition body 552. Thecomposition body 552 can be shaped or formed into a substantially flator sheet-like configuration. However, the composition body 552 can beflexible such that the composition body 552 can conform to or wraparound a portion of the three-dimensional shape of the implant 10.

In certain embodiments, the composition body 552 can define, e.g., arectangular shape, a square shape, an oval shape, a circular shape, orthe like. In certain embodiments, the composition body 552 can define ashape substantially complementary to the shape of the composition body502 of the first composition half 500. In certain embodiments, thesecond composition half 550 can include one or more mesh patterns 554formed therein. The mesh patterns 554 can be formed from a plurality ofslits 556 formed in and passing through the composition body 552. Incertain embodiments, the slits 556 can be formed in a horizontaldirection. In certain embodiments, the slits 556 can be formed in avertical direction. In certain embodiments, adjacent rows of slits 556can be staggered or offset relative to each other. In certainembodiments, the slits 556 can be linear, angled, a combination thereof,or the like. Each slit 556 can be configured and dimensioned to allowpassage of a single flap 504, 506, 510, 512 of the first compositionhalf 500 therethrough.

In certain embodiments, the mesh patterns 554 can be formed in asubstantial portion of the composition body 552 (e.g., covering thesurface area within the edges of the composition body 552). In certainembodiments, the mesh patterns 554 can be formed in a central portion ofthe composition body 552 (e.g., leaving portions of the composition body552 as continuous structures). In certain embodiments, the mesh patterns554 can be formed at the edges of the composition body 552 (e.g.,leaving the central area of the composition body 552 as a continuousstructure). As described above, the mesh patterns 554 allow portions ofthe composition body 552 to be expanded and stretched to conform thecomposition body 552 to the three-dimensional shape of the implant 10,thereby allowing the implant 10 to be at least partially wrapped withthe second composition half 550.

With reference to FIG. 18, a perspective view of the first and secondcomposition halves 500, 550 completely or nearly completely wrappedaround the implant 10 is provided. For example, the first compositionhalf 500 can wrap around and cover the anterior side 26 of the implant10, while the second composition half 550 can wrap around and cover theposterior side 28 of the implant 10. Initially, the implant 10 can bepositioned on or oriented relative to the first and/or secondcomposition half 500, 550 such that the appropriate sections of theimplant 10 that require additional support are positioned adjacent tocontinuous structure portions of the first and/or second compositionhalf 500, 550 (e.g., areas without the mesh pattern 516, 554).

In the initial configuration, the first and second composition halves500, 550 can be dimensioned smaller than half of the surface area of theimplant 10. However, as shown in FIG. 18, one or more areas of thecomposition bodies 502, 552 including the mesh patterns 516, 554 can beexpanded and stretched to at least partially wrap the first and secondcomposition halves 500, 550 around the implant 10. For example, the meshpattern 516 of the first composition half 500 can be expanded orstretched to wrap around portions of the posterior side 28 of theimplant 10. Similarly, the mesh patterns 554 of the second compositionhalf 550 can be expanded or stretched to wrap around portions of theanterior side 26 of the implant 10.

The mesh patterns 516, 554 can be expanded or stretched by applying atensile force on the edges of the composition body 502, 552. The slits518, 556 that form the mesh pattern 516, 554 can expand due to thetensile force to create a plurality of openings that are dimensionedgreater than the slits 518, 556 in the non-expanded configuration. Inparticular, due to the flexibility of the mesh patterns 516, 554, theexpansion and stretching of the mesh patterns 516, 554 can be customizedbased on the particular implant 10 configuration being used. Thus, lessmaterial can be used to wrap the first and second composition halves500, 550 around a variety of implants 10.

During the wrapping process, the implant 10 can be positioned on andorientated relative to the first composition half 500. The top andbottom edges 508, 514 of the first composition half 500 can be wrappedaround a portion of the implant 10 (e.g., the posterior side 28) suchthat the flaps 504, 506 extend over the top side of the implant 10 andthe flaps 510, 512 extend over the bottom side of the implant 10. As thefirst composition half 500 is wrapped around the implant 10, the meshpattern 516 can expand and stretch to conform the first composition half500 to the three-dimensional form of one half of the implant 10.

The second composition half 550 can be positioned on and orientedrelative to the implant 10. The second composition half 550 can bewrapped around a portion of the implant 10 (e.g., the anterior side 26)such that the top edge of the second composition half 550 is positionedadjacent to the flaps 504, 506 of the first composition half 500, andsuch that the bottom edge of the second composition half 550 ispositioned adjacent to the flaps 510, 512 of the first composition half500. As the second composition half 550 is wrapped around the implant10, the mesh patterns 554 can expand and stretch to conform the secondcomposition half 550 to the three-dimensional form of the opposing halfof the implant 10. The flaps 504, 506 can be passed through two slits556 of the mesh pattern 554 near the top edge of the second compositionhalf 550. Similarly, the flaps 510, 512 can be passed through two slits556 of the mesh pattern 554 near the bottom edge of the secondcomposition half 550.

In certain embodiments, suture 558 can be used to secure the flaps 504,506, 510, 512 to the composition body 552 such that the flaps 504, 506,510, 512 cannot pass out of the slits 556. The flaps 504, 506, 510, 512thereby act as fastening elements and maintain the first and secondcomposition halves 500, 552 stretched and wrapped around the implant 10.In particular, the flaps 504, 506, 510, 512 maintain the first andsecond halves 500, 550 interlocked relative to each other. In certainembodiments, the first and second composition halves 500, 550 caninclude flaps extending from side edges such that the sides of theimplant 10 can be fully covered by the first and second compositionhalves 500, 550 in the wrapped configuration.

The compositions described herein can therefore be implemented to coveran implant or tissue expander in an adjustable manner. In particular,the compositions include one or more mesh patterns formed therein thatallow for expansion and stretching of the composition body to conform tothe three-dimensional shape and size of the implant or tissue expander.Thus, a smaller amount of material can be used to form the compositions,while ensuring that sufficient coverage and support is provided to theimplant or tissue expander.

Although the compositions, systems and methods of the present disclosurehave been described with reference to exemplary embodiments thereof, thepresent disclosure is not limited to such exemplary embodiments and orimplementations. Rather, the compositions and methods of the presentdisclosure are susceptible to many implementations and applications, aswill be readily apparent to persons skilled in the art from thedisclosure hereof. The present disclosure expressly encompasses suchmodifications, enhancements and or variations of the disclosedembodiments. Since many changes could be made in the above exemplaryembodiments and many widely different embodiments of this disclosurecould be made without departing from the scope thereof, it is intendedthat all matter contained in the drawings and specification shall beinterpreted as illustrative and not in a limiting sense. Additionalmodifications, changes, and substitutions are intended in the foregoingdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the scope of thedisclosure.

1. A composition for treatment, comprising: a composition body; and amesh pattern formed in at least a portion of the composition body;wherein the composition body comprises a tissue matrix or syntheticmaterial; and wherein the composition body is configured to stretch andexpand at the mesh pattern to completely or nearly completely wrap thecomposition body around or position the composition body onto an implantor a tissue expander.
 2. The composition of claim 1, wherein the tissuematrix is an acellular tissue matrix.
 3. The composition of claim 1,wherein the composition body comprises a central region and at least twoextensions protruding from opposing sides of the central region, the atleast two extensions having the mesh pattern formed therein.
 4. Thecomposition of claim 3, wherein the composition body is configured to bepositioned onto the implant or tissue expander with the central regionof the composition body disposed against an anterior side of the implantor tissue expander.
 5. The composition of claim 4, wherein the at leasttwo extensions are configured to be stretched and expanded at the meshpattern to wrap the composition body around the implant or tissueexpander such that one extension of the at least two extensions iswrapped in a first direction around the implant or tissue expander andanother extension of the at least two extensions is wrapped in anopposing direction to secure the composition body to the implant ortissue expander.
 6. The composition of claim 5, wherein the at least twoextensions are configured to be engaged with each other at a posteriorside of the implant or tissue expander, the posterior side opposing theanterior side of the implant or tissue expander.
 7. The composition ofclaim 3, wherein the composition body comprises at least two additionalextensions protruding form opposing sides of the central region.
 8. Thecomposition of claim 4, wherein the at least two additional extensionseach comprise a mesh pattern formed therein.
 9. The composition of claim3, wherein the central region comprises the mesh pattern formed therein.10. The composition of claim 1, wherein the tissue matrix is a tissuematrix sheet defining a planar and flexible configuration.
 11. Thecomposition of claim 3, comprising a fastening element configured tointerlock the at least two extensions relative to each other to securethe composition body to the implant or tissue expander.
 12. Thecomposition of claim 1, wherein the composition body comprises a topregion, a central region, and a bottom region, at least one strap beingintegrally formed adjacent to an edge of the bottom region.
 13. Thecomposition of claim 3, wherein the at least two extensions extendparallel to each other.
 14. The composition of claim 11, wherein thefastening element detachably interlocks the at least two extensions ofthe composition body.
 15. The composition of claim 11, wherein thefastening element includes an elongated body with a proximal end and adistal end, the proximal end including a rounded tip.
 16. Thecomposition of claim 15, wherein a diameter of the rounded tip isdimensioned greater than a width of the elongated body.
 17. Thecomposition of claim 16, wherein the rounded tip includes a slitconfigured to receive therethrough the distal end of the fasteningelement to interlock the fastening element to the at least twoextensions.
 18. The composition of claim 3, wherein the central regionof the composition body is mesh-free.
 19. The composition of claim 3,wherein: the composition body includes a horizontal axis passing throughthe central region, the at least two extensions protruding from theopposing sides of the central region and substantially parallel to thehorizontal axis; the composition body includes a vertical axis passingthrough the central region; and the composition body includes twoadditional extensions protruding from opposing sides of the centralregion and substantially parallel to the vertical axis.
 20. A system fortreatment, comprising: a composition, the composition including (i) atissue matrix or synthetic material defining a composition body, and(ii) a mesh pattern formed in at least a portion of the compositionbody; and an implant or a tissue expander; wherein the composition bodyis configured to stretch and expand at the mesh pattern to completely ornearly completely wrap the composition body around or position thecomposition body onto the implant or the tissue expander.